Date of event: unknown.The date received by manufacturer has been used for this field.No lot # provided.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Bd had conducted an on-site visit with the customer on (b)(4) 2017 and had reviewed proper pre-analytical processes, clotting times, centrifugation as well as provided educational information on erroneous potassium results.Following the visit, feedback from the customer indicates that they will be providing additional training to their staff.As no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.As there was no sample or photo available for evaluation, a root cause could not be determined.
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